Monday, February 27, 2012
Effects of Cobalt & Chromium in your Body
There is a very unique aspect to metal-on-metal hip implants that has been found dangerous to hip implant patients. In light of recent hip implant recalls, surgeons have come forward to reveal high failure rates in many large diaphragm metal-on-metal implants, and the significant damage they cause by way of metal wear debris. Click here for a list of metal-on-metal implants that may cause elevated cobalt and chromium blood levels. Metal wear debris has been found to cause soft tissue damage in and around the hip joint. Many studies suggest this is caused by both direct killing of the tissue, and also by a stimulation of an inflammatory process. Often patients who have been implanted with large diaphragm metal-on-metal hip implants have discovered pseudo-tumors growing in the tissue surrounding the metal hip. These benign tumors are growths of pus and scar tissue resulting from this inflammatory process that has occurred in response to the foreign object implanted in the body. (continued below)
| |||||
| |||||
This inflammatory process can also affect the body's immune response by infiltrating the T-lymphocytes, or T-cells, that drive up the body's hypersensitivity response. This is where the health consequences to cobalt and chromium become a larger concern. Cobalt has been known to trigger cardiomyopathy (heart problems), hypothyroidism, and both cobalt and chromium may possibly contribute to neurotoxic outcomes, as well as carcinogenesis, or cancer. According to the Agency for Toxic Substances & Disease Registry, cancer has been shown in animals when cobalt was placed directly into the muscle or under the skin. Based on this research, the World Health Organization's International Agency for Research on Cancer includes cobalt found in hard metals as a potential carcinogen for humans. Additional Reading: Four-year study of cobalt and chromium blood levels in patients managed with two different metal-on-metal total hip replacements, March 2003, Journal of Orthopaedic Research Read about the risks of metal-on-metal hip implants for pregnant women | |||||
| |||||
Cobalt & Chromium are my Concern
Metal Sensitivity (from Wikipedia)
Although little is known about the short and long term pharmacodynamics and bioavailability of circulating metal degradation products in vivo, there have been many reports of immunologic type responses temporally associated with implantation of metal components. Individual case reports link hypersensitivity immune reactions with adverse performance of metallic clinical cardiovascular, orthopedic and plastic surgical and dental implants. [9]
By 2010 reports in the orthopaedic literature have increasingly cited the problem of early failure of metal on metal prostheses in a small percentage of patients.[10] Failures may relate to release of minute metallic particles or metal ions from wear of the implants, causing pain and disability severe enough to require revision surgery in 1–3% of patients.[11] Design deficits of some prosthetic models, especially with heat-treated alloys and a lack of special surgical experience accounts for most of the failures. Surgeons at leading medical centers such as the Mayo Clinic have reported reducing by 80 percent their use of metal-on-metal implants over the last year in favor of those made from other materials, like combinations of metal and plastic.[12] The cause of these failures remain controversial, and may include both design factors, technique factors, and factors related to patient immune responses (allergy type reactions).
In the United Kingdom the Medicines and Healthcare products Regulatory Agencycommenced an annual monitoring regime for metal-on-metal hip replacement patients from May 2010.[13] Data which is shown in The Australian Orthopaedic Association's 2008 National Joint Replacement Registry, a record of nearly every hip implanted in that country over the previous 10 years, tracked 6,773 BHR (Birmingham Hip Resurfacing) Hips and found that less than one-third of one percent may have been revised due to the patient's reaction to the metal component.[14] Other similar metal-on-metal designs have not fared as well, where some reports show 76% to 100% of the people with these metal-on-metal implants and have aseptic implant failures requiring revision also have evidence of histological inflammation accompanied by extensive lymphocyte infiltrates, characteristic of delayed type hypersensitivity responses. [15] It is not clear to what extent this phenomenon negatively affects orthopedic patients. However for patients presenting with signs of an allergic reactions, evaluation for sensitivity should be conducted.
By 2010 reports in the orthopaedic literature have increasingly cited the problem of early failure of metal on metal prostheses in a small percentage of patients.[10] Failures may relate to release of minute metallic particles or metal ions from wear of the implants, causing pain and disability severe enough to require revision surgery in 1–3% of patients.[11] Design deficits of some prosthetic models, especially with heat-treated alloys and a lack of special surgical experience accounts for most of the failures. Surgeons at leading medical centers such as the Mayo Clinic have reported reducing by 80 percent their use of metal-on-metal implants over the last year in favor of those made from other materials, like combinations of metal and plastic.[12] The cause of these failures remain controversial, and may include both design factors, technique factors, and factors related to patient immune responses (allergy type reactions).
In the United Kingdom the Medicines and Healthcare products Regulatory Agencycommenced an annual monitoring regime for metal-on-metal hip replacement patients from May 2010.[13] Data which is shown in The Australian Orthopaedic Association's 2008 National Joint Replacement Registry, a record of nearly every hip implanted in that country over the previous 10 years, tracked 6,773 BHR (Birmingham Hip Resurfacing) Hips and found that less than one-third of one percent may have been revised due to the patient's reaction to the metal component.[14] Other similar metal-on-metal designs have not fared as well, where some reports show 76% to 100% of the people with these metal-on-metal implants and have aseptic implant failures requiring revision also have evidence of histological inflammation accompanied by extensive lymphocyte infiltrates, characteristic of delayed type hypersensitivity responses. [15] It is not clear to what extent this phenomenon negatively affects orthopedic patients. However for patients presenting with signs of an allergic reactions, evaluation for sensitivity should be conducted.
The animal that is the DePuy ASR
“Metal on Metal implants have drawn scrutiny because ware can kick up metal debris that damages surrounding muscle and tissue in some patients, thereby requiring that the implants be replaced earlier than usual…Surgeons try to avoid doing hip operations because ‘revision’ surgeries carry risks and successive implants don’t tend to fit as well as the first ones…revision surgeries ‘are technically more difficult, they take longer and the patient is more at risk of complications and the recovery is more prolonged…’revision’ surgeries are also expensive. “
Key Facts from the DePuy web site:
Which Hips have been recalled?
The Recalls involve two products post 2003:
· The ASR XL Acetabular System
· The ASR Hip Resurfacing System. (This one was never approved in the US and was only sold outside the country.)
The ASR Hip is made up of ball and socket components that move against each other. These metal components wear over time and generate very small particles that can only be seen with a microscope. This is an expected process. These particles do not cause problems for most patients, but a small number of patients may react to these particles, causing fluid to collect in the joint and in the muscles around the joint. While this condition may initially be painless, if left untreated, this reaction may cause pain and swelling around the joint and could damage some of the muscles, bones, and nerves around the hip.>>>>>>>Erm...liars!!! It now has a 50% failure rate. It has quadrupled from July 2010<<<<<<<<<<
My Story
MY STORY
I'm 33 years old, with a hip on a mission. I underwent a left hip resurfacing on 5th July 2010. It was the DePuy ASR, which has been under the spotlight since the recall on August 2010.
One month after my surgery!!The bad news is that I only found out "hap-hazardously" about the recall 2 weeks ago. The good news is that I can do something about it.
In 2 weeks I have been to hell and back trying to get answers, and for the past 18 months I have been tolerating a plethora of symptoms as a result of the implant. I hope that my story will help South Africans go about this the right way, without the trauma of being left in the dark about the reality of this thing.
WHY HIP RESURFACING AT SUCH A YOUNG AGE?
In 1995 I was the fastest woman on water in SA, water ski racing behind super-charged Chevrolet V8's, racing in the ocean in enduro's for as long as 2 hours @ 100km to 140km/h.
I had a serious fall at the World Championships in Belgium, and I was admitted to a Hospital in Blankenberg with a grade III MCL injury (medial collateral ligament of the knee), and a head injury. After a few stitches to the forehead, the only pain I could feel was in my knee. We suspect that I suffered a partial hip dislocation at the time, but I was not feeling pain in that area because the pain was deferred. Also, it was difficult talking to foreign doctors and explaining how I was feeling after concussion.
For years after this I dismissed the pain emanating from the left hip, and always thought that it was due to the strenuous exercise I was always doing. I continued wakeboarding - rode for one season of the SA Pro Tour Stop, and did my last water ski race in 2005 in England.
In 2009 I started swimming and had entered for the SA Masters Championships for 2010. My goal was to conquer! Once I had started daily training, I suffered intense pain in the hip, and couldn't walk for longer than 5 minutes, and I couldn't exercise without pain in my hip.
I saw my first orthopedic surgeon in February, who told me I had necrosis of the femoral head. I could NOT believe him when he told me I would need to have a hip replacement. AT MY AGE....JA RIGHT!
I was determined to prove him wrong. I went for 2 other opinions and they all came back with the same conclusion. Refusing to accept this, I started my research.
I read all about hip replacements and became petrified that I would feel like an old woman, with no chance of conquering my sport, with limited mobility, and a lifetime of "being careful".
I found out about "hip resurfacing", a new technology and approach which is the perfect alternative for young patients.
WHAT'S THE DIFFERENCE?
This is taken from Wikipedia:
Hip resurfacing has been developed as a surgical alternative to total hip replacement (THR). The procedure consists of placing a cobalt-chrome metal cap, which is hollow and shaped like a mushroom, over the head of the femur while a matching metal cup (similar to what is used with a THR) is placed in the acetabulum (pelvis socket), replacing the articulating surfaces of the patient's hip joint and removing very little bone compared to a THR. When the patient moves the hip, the movement of the joint induces synovial fluid to flow between the hard metal bearing surfaces lubricating them when the components are placed in the correct position. The surgeon's level of experience with hip resurfacing is most important; therefore, the selection of the right surgeon is crucial for a successful outcome.
WHY WAS MY PROSTHESIS, THE DEPUY ASR RECALLED?
It was recalled because of it's high failure rate. Surgeons and studies expect the DePuy ASR to reach a 100% failure rate within the next few years. Please watch this awesome video explaining why it was recalled:
Questions for the Nephrologist
With many thanks to Connie from http://www.mydepuyhiprecall.com:
Implications of Ion Toxicity on the kidneys (Questions that must be answered.)
Questions for my consults (in no particular order):
1) What is the cancer risk in the kidney given the statistically significant results found in the Sweden study?
2) What is the risk of a trivalent chromium being a carcinogen with the primary target being the kidney?
3) Kidney epithelial cells are 10x more sensitive towards Cr 6 than the same liver cells. Humm hepatoxic issues as well ?
4) Can non toxic Cr3 be oxidized to Cr 6 under certain conditions and what are they? (very important question/studies indicate yes.)
5) What is the toxic range for Cr and Co in the kidney?
6) What are the signs for this?
7) What are the tests for measuring the accumulation of these metals in the kidneys?
8) What is my risk given I have only one left?
9) What is the risk differentiator with metal implants vs inhaled or oral exposure? Studies seem to be focused on the latter not the former?
10) What are the genotoxic effects for a trivalent Cr to the kidney?
11) What oxidation is this metal exposed to in the body once it is in there?
12) What solubility issues should be considered?
13) Once absorbed, Cr 6 IS QUICKLY REDUCED TO THE TIRVALENT FORM WHICH ACCOUNTS FOR ALL OF THIE ELEMENT PRESENT IN THE BLOOD STREAM OR TAKEN UP BY THE TISSUE? What?? Then how is CR 6 responsible for cancer and other things if it is non toxic?
14) How is this absorbed by the kidney?
15) Two main features of kidney damage re metals: (Is this correct overall?)
a. Lack of dose-effect/response relationships or progression toward more severe impairment when the exposure intensity increases
b. The recent absorption rate more than the cumulated does is responsible for the observed nephrotoxic effects.
16) What is renal oligio anuric deficiency? How is it caused?
17) There is good evidence that Cr 6 is the ion responsible for MOST of the toxic actions although much of the underlying molecular damage may be due to the intracellular reduction to the even more highly reactive and short-lived Cr3 and Cr6. ??
18) What about Cobalt? “Patients with impaired renal function may experience Co poisoning without the presence of pain despite a well positioned implant because the cobalt released by normal implant wear is not adequately cleared by their kidneys? (2010/Alaska epidemiology)
19) In short term tests, the hexavalent Cr demonstrated genotoxic effects 4 times more frequently than did the trivalent Cr compounds. Well this is not comforting. This tells me that there are geneotoxic effects with trivalent as well. So what are they?
Kidney Check
I have learnt a big lesson from this - IT'S YOUR LIFE; TAKE IT INTO YOUR OWN HANDS!
If I had waited for medical professionals to come to my rescue, I would probably be near dead in 3 years time.
My urine pathology came back and I'm investigating it. I see something that raises a red flag: GFR=65 ml/min.
I got the FAQ from the National Kidney Foundation about GFR Estimates, and here is some vital information:
"1) What is GFR? {My notes: it's the basic measuring of kidney function}
GFR (glomerular filtration rate) is equal to the total of the filtration rates of the functioning nephrons in the kidney.
3) What does GFR indicate? {My notes: my GFR is less than half of what it should be. ALARM BELLS!}
GFR is usually accepted as the best overall index of kidney function. A clinician or medical laboratory can estimate GFR from a person’s serum creatinine level and some or all of the following variables: gender, age, weight, and race.
Normal GFR varies according to age, sex, and body size; in young adults it is approximately 120-130 mL/min/1.73 m2 and declines with age. A decrease in GFR precedes the onset of kidney failure; therefore, a persistently reduced GFR is a specific diagnostic criterion for chronic kidney disease (CKD). Below 60 mL/min/1.73 m2, the prevalence of complications of CKD increases, as does the risk of cardiovascular disease (CVD).
This is very interesting, taken from http://mydepuyhiprecall.com:
If I had waited for medical professionals to come to my rescue, I would probably be near dead in 3 years time.
My urine pathology came back and I'm investigating it. I see something that raises a red flag: GFR=65 ml/min.
I got the FAQ from the National Kidney Foundation about GFR Estimates, and here is some vital information:
"1) What is GFR? {My notes: it's the basic measuring of kidney function}
GFR (glomerular filtration rate) is equal to the total of the filtration rates of the functioning nephrons in the kidney.
3) What does GFR indicate? {My notes: my GFR is less than half of what it should be. ALARM BELLS!}
GFR is usually accepted as the best overall index of kidney function. A clinician or medical laboratory can estimate GFR from a person’s serum creatinine level and some or all of the following variables: gender, age, weight, and race.
Normal GFR varies according to age, sex, and body size; in young adults it is approximately 120-130 mL/min/1.73 m2 and declines with age. A decrease in GFR precedes the onset of kidney failure; therefore, a persistently reduced GFR is a specific diagnostic criterion for chronic kidney disease (CKD). Below 60 mL/min/1.73 m2, the prevalence of complications of CKD increases, as does the risk of cardiovascular disease (CVD).
This is very interesting, taken from http://mydepuyhiprecall.com:
Nine-Year Incidence of Kidney Disease in Patients Who Have had Total Hip Arthroplasty.
Chandran SE, Giori NJ. J Arthroplasty. 2011 Apr 18. [Epub ahead of print]
Department of Orthopedic Surgery, Stanford University, Stanford, California.
Abstract
Metal-metal total hip arthroplasty (THA) is contraindicated in patients with impaired renal function due to increased metal ion output relative to other bearings and renal excretion of metal ions. Although one can avoid a metal-metal THA in a patient with renal disease, a patient may be destined to develop renal disease later in life. In this study, we sought to determine the incidence of newly diagnosed renal disease in the 9 years after THA. Using the Department of Veterans Affairs national database, we identified 1709 patients who had a primary THA in 2000without preexisting renal disease. We found the 9-year risk of developing chronic renal disease after primary THA to be 14% and severe or end-stage renal disease to be 6%
xxxx
What a difference 3 years make! Very interesting indeed."
I have made an appointment with a nephrologist, and will update again on progress, results and findings.
Subscribe to:
Posts (Atom)